Applications for Changes of the Labelling or PIL Not Associated with SmPC (Type P Variations)
SÚKL informs marketing authorisation holders (MAH) about the aspects of submitting applications for changes of the labelling or PIL not associated with the SmPC (Notification under Article 61(3) of Directive 2001/83/EC and under Section 35(5) of the Act on Pharmaceuticals; so called Type P variations), incl. procedural differences between national and MRP variations and how to distinguish between them in specific cases.
29. 08. 2022Applications for Transfers of Marketing Authorisations of Medicinal Products
SÚKL informs marketing authorisation holders about the aspects of submitting applications for transfers of the medicinal product marketing authorisations, including information on differences between marketing authorisation transfers effective as of the date when the decisions on the marketing authorisation transfers come into force or as of a future date. The provided information applies to medicinal products authorised via national procedures as well as MRP/DCP.
25. 08. 2022Applications for Revocation of Marketing Authorisations of Medicinal Products
SÚKL hereby informs marketing authorisation holders about the aspects of submitting applications for revocation of the medicinal product marketing authorisations, including information on medicinal product recalls following the revocation of their marketing authorisations.
10. 12. 2021Notification of Request for Exemption to Continue Medicinal Product Batch Control Testing in the United Kingdom (UK) after Brexit
SÚKL hereby informs marketing authorisation holders on cases of notification of request for a time-limited exemption to continue medicinal product batch control testing in the UK for medicinal products authorised via the MRP/DCP.
11. 03. 2019Waiver of Reimbursement of Costs for Additional Strengths/Pharmaceutical Forms of a Particular Product upon Take-over of the Role of the RMS Due to Brexit
Upon request, SÚKL shall waive the payment of reimbursement of costs for additional strengths/pharmaceutical forms of a medicinal product in respect of which it will take over the role of the RMS from Great Britain in the period from 1 December 2018 to 29 March 2019.
13. 11. 2018Reminder of the method of provision of information upon suspension or termination of marketing of medicinal products
SÚKL hereby reminds marketing authorisation holders of the necessity to provide available information when reporting suspension or termination of marketing of a medicinal product in the Czech Republic.
29. 09. 2015Centralised Procedure Documentation – change in submission to Czech NCA
The introduction of the Common Repository in February 2014 by European Medicines Agency has enabled Czech NCA to use the system as the only source of Centralised Procedure submissions, therefore there is no longer required to submit additional copies of submissions in form of CDs/DVDs by mail. This applies to all types of Centralised Procedure related to centrally authorised products submitted in eCTD format apart of listed exceptions.
11. 08. 2014Changes in Sending Decisions/Notifications/Notices to Physical Entities and Foreign Legal Entities without a Data Box
The State Institute for Drug Control (hereinafter referred to only as the “Institute”) informs marketing authorisation holders about the new method of sending the decisions/notifications/notices concerning applications for marketing authorisation, renewal, variation, transfer of marketing authorisation as well as applications for parallel import authorisation, etc. to physical entities and foreign legal entities without a data box, with effect from November 6, 2013.
5. 11. 2013Information on the duty to use certified electronic signature in communication with the State Institute for Drug Control
The State Institute for Drug Control (“Institute”) informs marketing authorisation holder on options of submission of amendment and of their duty to use email with the certified electronic signature in their official communications with the Institute (e.g. when submitting additional dossier in administrative proceedings, national translations of the SmPC, PIL and labelling).
23. 10. 2013Obligations Applicable to Holders of Centralised Marketing Authorisations
Obligations applicable to Marketing Authorisation Holders of Products Authorised via the Centralised Procedure in relation to State Institute for Drug Control.
10. 05. 2013Change concerning the submitting of applications for renewal of marketing authorisation
The State Institute for Drug Control (SÚKL) hereby informs of a change concerning the submitting of applications for renewal of marketing authorisation introduced by the amended Act on Pharmaceuticals.
21. 03. 2013Termination of MRP type I and II variations without a decision on marketing authorisation variation
Information for marketing authorisation holders
22. 05. 2012Finalisation of MRP variations type I without notification
Information for marketing authorisation holder.
13. 10. 2009Information on the EU Synchronisation of PSUR submission
SÚKL Information for Marketing Authorisation Holders on the EU Synchronisation of PSUR submission schemes of medicinal products authorised through national, mutual recognition and decentralised procedures.
11. 04. 2007
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